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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Päijänne Tavastia Central Hospital | OTHER |
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In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study group | Active Comparator | The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit |
|
| The control group | Placebo Comparator | The control group will be given colored water at same timepoints |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Other | Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified gut microbiota composition | Increased species richness and alfa-diversity | at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimmo K Salminen, MD, PhD | Contact | +35823130691 | kimmo.salminen@tyks.fi | |
| Jaakko Rautakorpi, MD | Contact | +358238027 | jaakko.rautakorpi@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Kimmo K Salminen, MD,PhD | Head of the section | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimmo Salminen | Recruiting | Turku | 20521 | Finland |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
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e
| Colored water | Other | Colored water (placebo) |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |